To obtain U.S. FDA approval in January 2016, Bracco Diagnostics performed extensive testing to demonstrate the safety of the new CT Exprès contrast management system. The goal was to provide users with a high degree of confidence that CT Exprès could be used safely. Testing was performed under rigorous conditions of simulated use/misuse, of CT Exprès with the Isovue® (Iopamidol Injection) Imaging Bulk Package (IBP) and saline. Protocols were reviewed and agreed upon with FDA prior to testing.1

Testing sought to confirm that formulations did not support microbial growth at a minimum through the period of time that the Isovue® (Iopamidol Injection) Imaging Bulk Package or saline bag may be used after the container closure is pierced (10 hours).1

DEMONSTRATED SAFETY

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METHODS

Antimicrobial effectiveness

ISOVUE-300 and -370 and saline were tested.1

7 test organisms were introduced separately, each at a final concentration of 105 – 106 CFU/mL (colony forming units per mL).1

All formulations were tested in accordance with United States Pharmacopeia 37, National Formulary 32, 2014, General Chapters, General Requirements, Microbiological Tests <51> Antimicrobial Effectiveness Testing.1

*Microorganisms and time points were tested in addition to those required by USP <51>.

DEMONSTRATED SAFETY

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RESULTS

Antimicrobial effectiveness

All formulations were bacteriostatic for up to 14 days at a minimum, which is well past the labeled usage time of 10 hours for the Isovue® IBP once the container closure is penetrated.1

DEMONSTRATED SAFETY

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PURPOSE

Microbial ingress

Keeping bacteria at bay

Testing sought to demonstrate that even under conditions of gross contamination, microorganisms did not enter the fluid path.1

Simulated use studies were performed simulating high and low volume use situations.

Simulated patient injections were collected and evaluated for sterility in accordance with United States Pharmacopeia 37, National Formulary 32, 2014, General Chapters, General Requirements, Microbiological Tests <71> Sterility Tests.

All test samples were confirmed as sterile. The results of this study demonstrate, in 304 test samples, the ability of CT Exprès as used with the Isovue® IBP and saline, to resist ingress of microorganisms into the fluid path, even under conditions of gross contamination, confirming the delivery of a sterile dose to the patient.1

DEMONSTRATED SAFETY

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PURPOSE

Cross-contamination

Rigorously tested safety features

CT Exprès engineering specifically addresses the needs of multi-patient use. It incorporates innovative design features specifically designed to prevent cross contamination—helping to maintain safety from the first patient to the last:

Uni-directional rotation of the pump motor at all times, producing positive displacement and pressure to the fluid outlet.

Two points of fully sealed compression that prevent backwash. Never at any point is there an open path on the injector.

Mechanical, software, and labeling protection against inadvertent reuse of the single-use-only Patient Set from patient to patient.

No vacuum producing means to cause reverse fluid motion and retrograde contamination from the patient connection.

These features have been subjected to further stringent testing to prove that–even under extreme and highly improbable conditions–patient-to-patient cross contamination will not occur.

DEMONSTRATED SAFETY

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METHODS

Cross-contamination

Employed a worst-case scenario in which a Patient Set was filled with red dye concentrate (simulating whole blood) when the Patient Set was connected to a saline primed Day Set.1

The distal end of the Patient Set was elevated to the maximum height possible above the connection to CT Exprès, and the system was allowed to sit passively for 30 minutes.1

At the end of the 30-minute period, the contaminated Patient Set was removed and a new Patient Set installed.1*

Samples were taken using the new Patient Set and quantitatively assayed for the presence of red dye by spectrophotometry.1

This challenge was performed 60 times1:

For each replicate, the saline bottle (surrogate for contrast), the saline bag, Bottle Spike, Day Set III HP, and the Patient Sets were replaced.1

DEMONSTRATED SAFETY

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RESULTS

Cross-contamination

All test samples were negative for the presence of dye. This demonstrates, with a high level of confidence, the ability of CT-Exprès, when used with the Isovue IBP and saline bags, to prevent cross-contamination (patient-to-patient contamination) even under extreme and highly improbable worst-case conditions.1

DEMONSTRATED SAFETY

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PURPOSE

Chemical compatibility

Preserving integrity and purity

Testing sought to demonstrate that the chemical integrity of Isovue® and saline is maintained during use.1

DEMONSTRATED SAFETY

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METHODS

Chemical compatibility

In a worst-case simulated use study,1 Isovue® IBP and saline were evaluated. The study was based on a usage time of 14 hours, which is 4 hours past the 10-hour labeled usage time for the Isovue IBP, saline (when used with Isovue and CT Exprès), and CT Expres Day Set.1

Experienced 2 hours of testing based on use scenarios representing the primary operating functions of the CT Exprès 3D Injector and at least 2 “off-normal” or unusual situations to evaluate the users’ ability to resolve problems and move forward.1

DEMONSTRATED SAFETY

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RESULTS

Human factors

The study demonstrates that CT Exprès can be used by representative users under simulated use conditions without producing patterns of failures that could result in a negative clinical impact to patients or harm to CT Exprès users.1

The individuals who appear are for illustrative purposes only.
All persons depicted are models and not real patients.

Isovue IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as Isovue-M® for intrathecal administration.

Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger and repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

*The Isovue Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.

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INDICATIONS:
The CT Exprès 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Exprès 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue® (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set must be discarded after each patient procedure.

The CT Exprès 3D is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

CONTRAINDICATIONS
This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.

Isovue and Isovue-M are registered trademarks of Bracco Diagnostics Inc.CT Exprès is a trademark of Bracco Injeneering S.A.

Not all products are available in all countries. Please contact your Bracco representative.

Bracco Injeneering S.A. reserves the right at any time and without notice, to change the specifications and features described herein, or to change the production or adjust the product described.

Isovue and Isovue-M are currently manufactured for Bracco Diagnostics Inc. at two locations:
BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino (Italy).